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Tasigna Approved in Switzerland for Leukemia

July 26, 2007

According to Norvartis, Swissmedic, the Swiss health authority, has granted the first approval for the company’s Tasigna for patients with a form of chronic myeloid leukemia who are resistant or intolerant to treatment with Glivec, another Novartis drug.

The approval of Tasigna (nilotinib) came after a pivotal Phase II trial, that showed high response rates and a generally well-tolerated, manageable safety profile, Novartis said.
 
According to the company, when taken twice-daily, Tasigna inhibits production of cancer cells containing an abnormal chromosome by targeting the Bcr-Abl protein.

Additional regulatory decisions on Tasigna are expected in the U.S. and Europe later this year, while a regulatory submission was completed in Japan during the second quarter, the company added.